|Orexigen Reports Progress on Resubmission of Contrave NDA; Intercept Begins Phase 2 NASH Trial of OCA|
|By Staff and Wire Reports|
|Monday, 07 January 2013 20:07|
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, announced progress with the United States Food and Drug Administration (FDA) on a faster path to resubmission of the Contrave® (naltrexone SR / bupropion SR) New Drug Application (NDA).
Consistent with the spirit of the formal dispute resolution request (FDRR) response letter issued to the Company in October by the FDA's Center for Drug Evaluation and Research, the Division of Metabolism and Endocrinology Products (DMEP) has proposed a resubmission procedure that allows the independent Data Monitoring Committee's summary report of the Light Study interim analysis to form the basis of the resubmission of the Contrave NDA. The complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the NDA resubmission filing, would be supplied to the FDA during the review within 60 days of the NDA resubmission.
The Data Monitoring Committee will conduct the interim analysis after at least 87 major adverse cardiovascular events (MACE) are adjudicated in the Light Study. The timing of the interim analysis is dependent upon the rate of MACE in the Light Study. Although the annual MACE rate is still too early to predict, if it is close to the target of 1.5%, Orexigen anticipates conducting the interim analysis and resubmitting the Contrave NDA in the second half of 2013 with potential approval in early 2014.
Orexigen also announced continued preparation for commercialization of Contrave, if approved, with plans to initiate the Ignite Study, a randomized open-label clinical trial designed to provide additional information regarding the real world weight loss potential of Contrave therapy with a commercially available comprehensive lifestyle intervention program versus usual care. Orexigen plans to initiate randomization of approximately 200 patients into the Ignite Study later this quarter.
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, announced its partner Dainippon Sumitomo Pharma (DSP) has initiated a phase 2 clinical trial of obeticholic acid (OCA) in adult nonalcoholic steatohepatitis (NASH) patients in Japan.
The trial is studying the efficacy and safety of a once daily dose of OCA, with the goal of randomizing 200 NASH patients to receiving OCA or placebo. The primary endpoint will be evaluated by histological improvement. DSP expects to complete the trial in the first half of 2016.
Align Technology, Inc. (NASDAQ: ALGN) today announced the new iTero imaging system available as a single hardware platform with software options for restorative or orthodontic procedures.
Alliqua, Inc. (OTCQB:ALQA) ("Alliqua" or the "Company") today announced that James Sapirstein, President and CEO, of Alliqua will present an overview of the Company's business and recent developments at Biotech Showcase 2013, held January 7-9, 2013, at the Parc 55 Wyndham Union Square Hotel in San Francisco, California.
Rhode Island-based electronics manufacturer Astro-Med, Inc. (NASDAQ: ALOT) issued a joint press release earlier today with Natus Medical Incorporated (NASDAQ: BABY) announcing that Astro-Med has entered into a definitive agreement to sell its Grass Technologies business segment.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today that, based on a preliminary review of its financial performance for the fourth quarter ended December 31, 2012, the Company expects to exceed its previous guidance and report net revenue in excess of $18 million.
The President of Cytta Corp. (OTCBB: CYCA) (OTCQB: CYCA), manufacturer of the CyttaConnect Open Source mobile monitoring technology, has issued the following update outlining the Company's future plans in anticipation of their upcoming licensing meetings at CES this week.
HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it expects total revenues for the fourth quarter of 2012 will be approximately $32 million, bringing expected full-year 2012 revenues to approximately $110 million.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 31st Annual J.P. Morgan Healthcare Conference, being held January 7-10, 2013, in San Francisco, CA. Mr. Bentsur's presentation is scheduled to take place on Thursday, January 10th, at 9:00 AM Pacific Standard Time (12:00 PM EST).
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reviewed 2012 accomplishments and announced several 2013 business updates, which the company discussed during its presentation at the 31st Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2013 at 9:30 a.m. Pacific Time.
Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) announced today that it exceeded its goal for new placements of the QIAsymphony modular laboratory workflow platform in 2012.
IMDx (privately held) announced today that it has entered into a multi-year development and license agreement with QIAGEN (NASDAQ: QGEN, Frankfurt Prime Standard: QIA) to design, develop and manufacture several undisclosed CE-marked and FDA cleared diagnostic tests for use on QIAGEN's flagship QIAsymphony RGQ automated platform. Financial terms have not been disclosed.
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the completion of approval of its AMPSA products with Brazil's National Health Surveillance Agency ("ANVISA") for immediate sale into the Brazilian market.
TRIMEDYNE, INC. ("Trimedyne") (OTCBB: TMED), today announced that John C. Chiu, M.D., an internationally respected neurosurgeon who practices in Newbury Park, CA, has agreed to serve as Medical Director and Chief Investigator of the three (3) randomized, controlled clinical trials to be conducted, subject to receiving funding, by Orthodyne, Inc., ("Orthodyne"), a subsidiary being a organized by Trimedyne.